Systems and methods for endoluminal valve creation

Abstract

Systems and methods for creating autologous monocuspid and bicuspid valves can include a catheter having a single expandable element or a double expandable element. Once the leaflets of the valve are created, various techniques can be used to fix the leaflets to the vessel wall or to each other, including clips, tissue anchors, adhesives, and heat.

What is claimed is: 
     
       1. A catheter system for dissecting a vessel wall at a treatment site, the catheter system comprising:
 a catheter having a proximal portion, a distal portion, and a lumen extending through at least a portion of the catheter, wherein the distal portion includes a trough having support rails configured to contact the vessel wall tissue at the treatment site; and 
 a dissection assembly configured to be slidably received within the lumen, wherein the dissection assembly includes—
 a puncture element having a distal end portion shaped to puncture the vessel wall; 
 a puncture element sheath configured to be advanced distally beyond the distal end portion of the puncture element to shield tissue of the vessel wall from the puncture element; and 
 a dilator having a dilator lumen configured to slidably receive the puncture element. 
 
 
     
     
       2. The catheter system of  claim 1  wherein the puncture element is configured to eject pressurized fluid while being advanced within the vessel wall to form a hydrodissection pocket within the vessel wall. 
     
     
       3. The catheter system of  claim 2  wherein the puncture element sheath is configured to be advanced over the puncture element while the puncture element ejects the pressurized fluid such that the puncture element sheath shields the tissue of the vessel wall during formation of the hydrodissection pocket. 
     
     
       4. The catheter system of  claim 1  wherein:
 the lumen of the catheter is a tool lumen; 
 the catheter further comprises a visualization lumen in communication with the trough; and 
 the catheter system further comprises a visualization catheter configured to be advanced through the visualization lumen into the trough. 
 
     
     
       5. The catheter system of  claim 1  wherein the dilator comprises wings configured to expand laterally outward when positioned in sub-intimal space within the vessel wall to dissect a portion of the vessel wall. 
     
     
       6. The catheter system of  claim 1  wherein:
 the lumen defines a boundary between a first side of the catheter and a second side of the catheter, the trough being open to the first side; 
 the catheter further comprises an apposition balloon at the distal portion and on the second side of the catheter; and 
 the catheter system is configured such that, when the catheter system is positioned at the treatment site, inflation of the apposition balloon radially outward from the second side causes the support rails to contact the vessel wall. 
 
     
     
       7. A catheter system for forming a hydrodissection pouch within a vessel wall at a treatment site, the catheter system comprising:
 a catheter having a proximal portion, a distal portion, and a lumen extending through at least a portion of the catheter, wherein the distal portion includes a trough having support rails configured to contact vessel wall tissue at the treatment site; and 
 a dissection assembly configured to be slidably received within the lumen, wherein the dissection assembly includes—
 a puncture element having a distal end portion shaped to puncture the vessel wall, wherein the puncture element is configured to be fluidly coupled to a source of pressurized fluid and eject the pressurized fluid while being advanced within the vessel wall to form the hydrodissection pouch; 
 a puncture element sheath configured to be advanced distally beyond the end portion of the puncture element to shield tissue of the vessel wall from the puncture element during formation of the hydrodissection pouch; and 
 a dilator having a dilator lumen configured to slidably receive the puncture element, the dilator configured to expand when positioned within the vessel wall to increase a dimension of the hydrodissection pouch. 
 
 
     
     
       8. The catheter system of  claim 7 , further comprising a visualization catheter, wherein the trough is configured to slidably receive a visualization catheter. 
     
     
       9. The catheter system of  claim 7  wherein the catheter further includes:
 an inflation lumen extending through at least a portion of the catheter; and 
 an apposition balloon at the distal portion and fluidly coupled to the inflation lumen. 
 
     
     
       10. A catheter system for dissecting a vessel wall at a treatment site, the catheter system comprising:
 a catheter including—
 a proximal portion; 
 a distal portion; 
 support rails at the distal portion and spaced apart from each other by a trough, wherein the support rails are configured to contact vessel wall tissue at the treatment site; 
 a tool lumen extending through at least a portion of the catheter and having an exit port at the distal portion, wherein the tool lumen is longitudinally aligned with at least a portion of the trough and at least a portion of the exit port is positioned outside of the trough; and 
 a visualization lumen extending through at least a portion of the catheter and in communication with the trough, wherein the visualization lumen is configured to guide a visualization device into the trough at a position spaced radially apart from the support rails; and 
 
 a dissection assembly configured to be slidably received within the tool lumen, wherein the dissection assembly includes—
 a puncture element having a distal end portion shaped to puncture the vessel wall; and 
 a dilator configured to be expanded from within a sub-intimal plane of a vessel wall to create a tissue flap. 
 
 
     
     
       11. The catheter system of  claim 10  wherein the puncture element is configured to be fluidly coupled to a source of pressurized fluid and eject the pressurized fluid while being advanced within the vessel wall to form a hydrodissection pocket within the vessel wall. 
     
     
       12. The catheter system of  claim 10  wherein the dilator has a dilator lumen configured to slidably receive the puncture element. 
     
     
       13. The catheter system of  claim 11 , further comprising a puncture element sheath configured to be advanced distally beyond the a distal end of the puncture element while the puncture element ejects the pressurized fluid in the vessel wall such that the puncture element sheath shields the tissue of the vessel wall from the puncture element during formation of the hydrodissection you pocket. 
     
     
       14. The catheter system of  claim 10  wherein the dissection assembly further comprises an access sheath configured to be advanced within the tool lumen over the puncture element. 
     
     
       15. The catheter system of  claim 10  wherein the catheter further includes:
 an inflation lumen extending through at least a portion of the catheter; and 
 an apposition balloon at the distal portion and fluidly coupled to the inflation lumen, 
 wherein, when the catheter system is positioned at the treatment site, inflation of the apposition balloon via the inflation lumen causes the support rails to contact the vessel wall.